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Annals of Oncology Advance Access published online on July 21, 2009
Annals of Oncology, doi:10.1093/annonc/mdp272
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

A randomized study comparing short-time infusion of oxaliplatin in combination with capecitabine XELOX30 and chronomodulated XELOX30 as first-line therapy in patients with advanced colorectal cancer

C. Qvortrup1,2,*, B. V. Jensen3, T. Fokstuen4, S. E. Nielsen5, N. Keldsen6, B. Glimelius4,7, B. Bjerregaard8, J. Mejer9, F. O. Larsen10 and P. Pfeiffer1,2

1 Department of Oncology, Odense University Hospital, Odense
2 Institute of Clinical Research, University of Southern Denmark, Odense
3 Department of Oncology, Herlev University Hospital, Copenhagen, Denmark
4 Department of Oncology and Pathology, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden
5 Department of Oncology, Hillerod Hospital, Hillerod
6 Department of Oncology, Herning Hospital, Herning, Denmark
7 Department of Oncology, Radiology and Clinical Immunology, Academic Hospital, Uppsala University, Uppsala, Sweden
8 Department of Oncology, Esbjerg Hospital, Esbjerg
9 Department of Oncology, Naestved Hospital, Naestved
10 Department of Oncology, Roskilde Hospital, Roskilde, Denmark

* Correspondence to: Dr C. Qvortrup, Department of Oncology, Odense University Hospital, Sonder Boulevard 29, DK-5000 Odense C, Denmark. Tel: +45-65413147; Fax: +45-66135477; E-mail: camilla.qvortrup{at}ouh.regionsyddanmark.dk

Background: Chronotherapy is one of the several approaches to increase efficacy and reduce toxicity of chemotherapy. In a phase II study in the second-line in patients with metastatic colorectal cancer (mCRC), we found that chronomodulated XELOX (XELOX30Chron) was a well-tolerated regimen with potentially reduced toxicity.

Patients and methods: One hundred and forty-one patients with unresectable mCRC were enrolled in a randomized study comparing standard XELOX (XELOX30), arm A, and XELOX30Chron, arm B—both with short-time infusion of oxaliplatin—with the primary aim of reducing overall toxicity.

Results: Overall toxicity grade 2–4 was 90% versus 85%, P = 0.47 and grade 3–4 was 31% versus 37%, P = 0.6 in arm A and B, respectively. We found no significant differences in median overall survival (17.6 versus 15.5 months; P = 0.068) and median progression-free survival (8.9 versus 8.8 months; P = 0.7). The incidence of grade 3 neuropathy was 16% in arm A and 19% in arm B (P = 0.7) after a cumulative dose of oxaliplatin of 1000 mg/m2.

Conclusion: XELOX30Chron does not reduce toxicity or improve efficacy. A 30-min infusion of oxaliplatin is safe and does not increase the severity of chronic neuropathy.

capecitabine, chronotherapy, colorectal cancer, oxaliplatin, randomized, short-time infusion

Received for publication December 1, 2008. Revision received April 14, 2009. Accepted for publication April 15, 2009.


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